A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma

NCT07107178 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BT02-102
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with advanced melanoma,regardless of gender, aged between 18 and 75 years (inclusive). Participants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.

Conditions

Advanced Melanoma; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Adverse events

  Through the study completion, an average of 2 years

• Dose limited toxicity(DLT)

  Through the dose escalation phase, an average of 8 months

• Maximum tolerable dose(MTD)

  Through the dose escalation phase, an average of 8 months

• Recommended phase 2 dose(RP2D)

  Through the study completion, an average of 2 years

Secondary Outcomes (8)

• Objective response rate (ORR) on tumor assessments

  Through the study completion, an average of 2 years

• Progression-free survival (PFS) on tumor assessments

  Through the study completion, an average of 2 years

• Overall survival (OS)

  Through the study completion, an average of 2 years

• Duration of response (DoR) on tumor assessments

  Through the study completion, an average of 2 years

• Disease control rate (DCR) on tumor assessments

  Through the study completion, an average of 2 years

Study Arms (1)

dose escalation and expansion

EXPERIMENTAL

Drug: BT02

Interventions

BT02 DRUG

monoclonal antibody injection with intravenous administration every 2 or 3 weeks

dose escalation and expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic malignant melanoma (except for uveal melanoma) who have failed in the prior systemic therapy .
• Adequate organ and hematologic function.
• At least 1 extracranial measurable lesion.
• An ECOG activity status score of 0-1.
• A life expectancy of ≥ 3 months.
• Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
• Good compliance and willingness to follow up.

You may not qualify if:

• Prior to first dose, received systemic antitumor therapy , scheduled major surgical procedure within 4 weeks , received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.
• A history of active autoimmune disease within the past 2 years.
• A history of clinically significant cardiovascular disease, severe cardiac rhythm/conduction abnormalities or LVEF\<50%. A history of severe pulmonary disease that may lead to severe episodes of dyspnea.
• A severe acute or chronic infection when enrollment.
• Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
• Unresolved \> grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
• Clinically active CNS metastases or meningeal metastases.
• A history of other type of malignancies.
• Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
• Poor compliance.
• A history of alcohol/drugs abuse.
• Current pregnancy or breastfeeding.
• Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.

Sponsors & Collaborators

• Biotroy Therapeutics: lead
• Peking University Cancer Hospital and Institute: collaborator

Study Officials

• Jun Guo, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical development director

CONTACT

+86-18602185973; clin.oper@biotroy.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 6, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07